Z-0958-2015Class II

Philips Expression MR200 MRI Patient Monitoring System

Name: Z-0958-2015 Philips Expression MR200 MRI Patient Monitoring System
Creator: Invivo Corporation
Published: 2014-10-22
License: https://open.fda.gov/license/

Invivo Corporation / initiated 2014-10-22 / Terminated / root cause: design

FDA source

Invivo Corporation began a recall of Philips Expression MR200 MRI Patient Monitoring System on 2014-10-22. FDA classified it as Class II and gives the reason as "The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0958-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-22
Posted: 2015-01-13
Terminated: 2017-01-09
Recalling firm: Invivo Corporation
Product: Philips Expression MR200 MRI Patient Monitoring System.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.
Root cause tag: design
FDA root cause: Component design/selection
Action: Philips Medical Systems sent an Urgent - Medical Device Correction Letter dated October 22, 2014, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Our records indicate that you have an affected device. The following page provides additional instructions and actions that will be taken to address this problem. If you need any further information or support concerning this issue, please contact your local Philips representative: 877-468-4861 option 1, then option 2.
Quantity in commerce: 20
Distribution: CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.
Product codes and lots: Model No. 866120; Lot/ Serial Numbers: US33600065, US33600066, US33600075, US33600077, US33600078, US33600079; US33600080, US33600081, US33600082, US33600083, US33600084, US33600086, US33600087, US33600088, US33600089, US33600090, US33600091, US33600092, US33600093, US33600094.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0958-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0958-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-13

Product code MWI

K131382Class IIExpression Mr200 MRI Patient Monitoring System, Expression Ip5 Information PortalInvivo Corporation / cleared 2013-07-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)